The fallopian tubes, uterus, cervix, vagina and external genitalia are female accessory reproductive organs essential for human procreation. These organs exhibit cyclic cellular changes, and their secretory capability is induced by numerous endocrine, paracrine, and autocrine factors that are generated by the same tissues or other organs of the body. The accessory reproductive organs provide support for fertilization and early embryonic differentiation, allow pregnancy maintenance and fetal development, and finally, parturition and birth of the baby. Numerous studies have shown that various processes of early embryonic development, differentiation of the conceptus (fetus and placenta) and pregnancy conditions can be established by cellular and molecular markers in products derived from such organs. In addition, numerous diseases of accessory reproductive organs related to infertility, neoplasia, and infections can also be detected in secreted fluids, discharges and exfoliated cells of these organs.
Therefore, new devices and procedures have been developed for: (i) collection of human uterine and cervical cells and secretions produced naturally or that resulted from treatment with drugs and therapeutic procedures; (ii) collection of live cells from uterus and cervix and microbes to allow their in vitro culture, and preservation of macromolecules and biochemical components of such cells and secretions suitable for diagnostic tests by cellular and molecular methods; and (iii) collection of menstrual discharges and conception products of spontaneous abortions and premature births for diagnosis of metabolic diseases of the mother or disorders of conception. These devices are designed for self collection of biological products available for diagnosis of cancer and infertility diseases, assessment of microbial infections, and pregnancy statuses by cellular, biochemical and molecular analyses.
It is known that alumina particles or gels derived from aluminum oxides and hydroxides have absorption and desiccation properties. Another silica product useful in this regard is hydrogel. It allows efficient absorption of liquid because of its porous nature. In addition, bioploymers [e.g., (polyethylene glycol)] have been developed for protection and delivery of biologically active short-lived molecules. Utilizing such materials and others, effluent collection systems of capsules and pads, and supportive structures, for the human uterus and cervix, have been developed.
U.S. Pat. No. 5,725,481 dated Mar. 10, 1998 is directed to a method and apparatus for collecting vaginal fluid and vaginal cells including an absorbent device inserted within the vagina. The absorbent device includes a core having a highly absorbent material and an outer covering made of a porous material to permit fluid to pass into the inner core. The vaginal device described is distinctly different from this device with capsules of absorbent materials containing compounds for enhancing the subsequent diagnostic testing.